((Automated translation by Reuters, please see disclaimer
Servier Pharmaceuticals said Tuesday that the U.S. Food and Drug Administration has approved the French manufacturer’s treatment for a type of brain tumor, making it the first drug to be approved in the United States for the condition.
The drug, called voranigo, is used to treat a form of brain cancer called grade 2 IDH-mutant glioma in patients who have had surgery.
Gliomas, a type of brain cancer that can interfere with normal brain function, have so far only been treated by removing the tumor. Grade 2 IDH-mutant glioma is caused by mutations in a family of genes called isocitrate dehydrogenase, or IDH.
Voranigo was approved based on a late-stage trial, in which patients who took the treatment showed progression-free survival of 27.7 months, compared with 11.1 months for the placebo group.
In the United States, approximately 0.7 in 100,000 people have an IDH-mutant glioma.
With the approval, Agios Pharmaceuticals AGIO.O will receive up to $1.1 billion in milestone payments from Servier and Royalty Pharma RPRX.O .
In 2021, Agios sold its oncology business to Servier and received $1.8 billion in cash. It was also due to receive a $200 million milestone payment following FDA approval of voranigo and a 15% royalty on potential net sales of the drug in the United States.
In May of this year, Agios sold part of its royalty rights to Voranigo to Royalty Pharma. Under the terms of the deal, an FDA approval of the drug would result in a payment of $905 million to Agios.
